breakthrough therapy

Top 3 new drug approvalsHere are 3 of the top new drug approvals in late December and early January.
Real-world results determine value-based price for specialty drugsIn an era when adherence to specialty pharmaceuticals is disturbingly low, value-based pricing needs real-world results, not single-arm accelerated trials.
AstraZeneca drug a breakthrough therapy for bladder cancerFDA has granted breakthrough therapy designation for durvalumab (MEDI4736, AstraZeneca) for the treatment of urothelial bladder cancer.
5 things to know about Gilead’s new hep C drugGilead Sciences, which already makes the leading hepatitis C drugs Harvoni and Sovaldi, recently received priority review from FDA for a new Hepatitis C combination drug.
Pancreatic cancer: Targeted treatments hold promiseCenter for Drug Evaluation and Research (CDER) Trade Press Scientists are working to develop breakthrough therapies for pancreatic cancer, one of the deadliest cancers affecting men and women.
FDA approves Ibrance to treat metastatic breast cancerIbrance is a potent and selective inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, which complex with a regulatory protein, called cyclin, to control cancer cell cycling. The FDA has approved it for use in the treatment of metastatic breast cancer.
FDA grants Lucentis breakthrough therapy for diabetic retinopathyThe FDA has granted breakthrough therapy designation for Lucentis (ranibizumab, Genentech) for the treatment of diabetic retinopathy.
FDA grants breakthrough status to investigational, oral proteasome inhibitor for AL amyloidosisInvestigational, oral proteasome inhibitor, ixazomib (MLN9708, Takeda) has FDA has granted breakthrough therapy status for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. This is the first proteasome inhibitor and first investigational therapy for AL amyloidosis to receive breakthrough therapy designation.